Symptom ManagemenNCT07679165
The Impact of Symptom Management Nursing Intervention on the QoL of Patients With Advanced Lung Cancer: Mediation of Self-management Efficacy and Regulation of Psychological Resilience
A study testing routine nursing group and standardized systematic SM nursing group in people with Symptom Managemen and Late Stage Lung Cancer, run by Jie Zeng at 1 site in China.
Trial summary
Symptom management nursing intervention can improve the self-management efficacy, psychological resilience, and QoL of patients with advanced lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Symptom Managemen, Late Stage Lung Cancer, QoL
- What is being tested?
- routine nursing group and standardized systematic SM nursing group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2023to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the diagnostic criteria of primary lung cancer [9], the clinical stage was stage ⅢB-Ⅳ
- aged 18-75 years old
- Karnofsky performance status (KPS) ≥60 and expected survival ≥3 months
- Patients had clear consciousness and normal cognitive function, and could complete the questionnaire independently or with the assistance of the researcher
- have basic communication skills and can cooperate to complete the whole intervention
- Patients or their families informed and signed the consent form.
Who cannot join
- primary malignant tumors in other parts
- history of severe heart, liver, kidney and other important organ failure, severe infection or mental illness
- Unable to cooperate with the study due to cognitive impairment, visual and hearing impairment
- participating in other similar nursing intervention studies.
Trial locations and contacts
1 site in 1 country.
China1 site
Dahua Hospital, Xuhui District, Shanghai
Shanghai, Shanghai Municipality, 200031
About this study
Official title: Dahua Hospital, Xuhui District, Shanghai
Symptom management nursing intervention can improve the self-management efficacy, psychological resilience, and QoL of patients with advanced lung cancer.
Read the detailed description
Self management efficacy is an important mediating variable in the impact of Symptom management nursing intervention on patients' quality of life. Psychological resilience plays a negative moderating role in the effect of Symptom management nursing intervention. Late stage lung cancer patients with low psychological resilience can obtain more significant self management efficacy and quality of life improvement from Symptom management nursing intervention, and are the key beneficiaries of the intervention.
- Conditions
- Symptom Managemen, Late Stage Lung Cancer, QoL, Self Management Efficacy, Psychological Resilience, Mediating Effect
- Being tested
- routine nursing group, standardized systematic SM nursing group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine nursing groupOther
Patients in the routine group were given routine care, including disease monitoring, medication care, diet and nutrition guidance, basic life care, routine health education on admission and discharge, symptomatic treatment of patients' discomfort symptoms, telephone follow-up twice a week to understand the patient's condition, and no systematic and personalized SM nursing intervention.
standardized systematic SM nursing groupOther
On the basis of routine nursing, implementation of systematic SM nursing intervention for 8 weeks, the specific content is as follows: (1) The intervention group was established. (2) Baseline assessment and file establishment (within 24 hours of admission).(3) Implementation of core intervention (1st to 8th week).
| Study group | Role | What they receive |
|---|---|---|
| Routine nursing group | Other | Patients in the routine group were given routine care, including disease monitoring, medication care, diet and nutrition guidance, basic life care, routine health education on admission and discharge, symptomatic treatment of patients' discomfort symptoms, telephone follow-up twice a week to understand the patient's condition, and no systematic and personalized SM nursing intervention. Receives: Other: routine nursing group |
| standardized systematic SM nursing group | Other | On the basis of routine nursing, implementation of systematic SM nursing intervention for 8 weeks, the specific content is as follows: (1) The intervention group was established. (2) Baseline assessment and file establishment (within 24 hours of admission).(3) Implementation of core intervention (1st to 8th week). Receives: Other: standardized systematic SM nursing group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life as measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale
The Functional Assessment of Cancer Therapy-Lung (FACT-L) scale will be used to assess changes in quality of life in patients with advanced lung cancer. The scale consists of 36 items across five domains: physical health status, social and family conditions, emotional well-being, functional capability, and lung cancer-specific supplementary concerns. Each item is scored on a 0-4 Likert scale, with total scores ranging from 0 to 144. Higher scores indicate better quality of life. The scale has demonstrated good reliability and validity in Chinese populations (Cronbach's α = 0.88-0.92).
Measured: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
Secondary outcomes (2)
Change in Self-Management Efficacy as measured by the Strategies Used by People to Promote Health (SUPPH) Scale
The SUPPH scale will be used to assess changes in disease self-management efficacy. The scale includes 28 items across three dimensions: Positive Attitude, Self-Applied Stress Reduction, and Independent Decision-Making. Each item is scored on a 1-5 Likert scale, with total scores ranging from 28 to 140. Higher scores indicate greater self-management efficacy. The Chinese version has excellent reliability (Cronbach's α = 0.96 for the total scale).
Measured: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
Change in Psychological Resilience as measured by the Connor-Davidson Resilience Scale (CD-RISC)
The CD-RISC will be used to assess changes in psychological resilience. The scale measures three dimensions-Tenacity, Self-Improvement, and Optimism-using 25 items. Each item is rated on a 0-4 scale, with total scores ranging from 0 to 100. Higher scores indicate stronger psychological resilience. The Chinese version has demonstrated good reliability (Cronbach's α = 0.91).
Measured: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start10 Jun 2023
- Primary completion27 Oct 2024
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptom ManagemenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jie Zeng
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Jie Zeng, Dahua Hospital, Xuhui District, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679165
- Sponsor's protocol ID
- 20230509
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dahua Hospital, Xuhui District, Shanghai
- ClinicalTrials.gov ID
- NCT07679165
- Acronym / sponsor ID
- 20230509
- Conditions
- Symptom Managemen, Late Stage Lung Cancer, QoL, Self Management Efficacy, Psychological Resilience, Mediating Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Jie ZengOther government
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 27 Oct 2024 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Symptom management nursing intervention can improve the self-management efficacy, psychological resilience, and QoL of patients with advanced lung cancer.
Detailed description
Self management efficacy is an important mediating variable in the impact of Symptom management nursing intervention on patients' quality of life. Psychological resilience plays a negative moderating role in the effect of Symptom management nursing intervention. Late stage lung cancer patients with low psychological resilience can obtain more significant self management efficacy and quality of life improvement from Symptom management nursing intervention, and are the key beneficiaries of the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine nursing group | Other | Other: routine nursing groupPatients in the routine group were given routine care, including disease monitoring, medication care, diet and nutrition guidance, basic life care, routine health education on admission and discharge, symptomatic treatment of patients' discomfort symptoms, telephone follow-up twice a week to understand the patient's condition, and no systematic and personalized SM nursing intervention. |
| standardized systematic SM nursing group | Other | Other: standardized systematic SM nursing groupOn the basis of routine nursing, implementation of systematic SM nursing intervention for 8 weeks, the specific content is as follows: (1) The intervention group was established. (2) Baseline assessment and file establishment (within 24 hours of admission).(3) Implementation of core intervention (1st to 8th week). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- According to the diagnostic criteria of primary lung cancer [9], the clinical stage was stage ⅢB-Ⅳ
- aged 18-75 years old
- Karnofsky performance status (KPS) ≥60 and expected survival ≥3 months
- Patients had clear consciousness and normal cognitive function, and could complete the questionnaire independently or with the assistance of the researcher
- have basic communication skills and can cooperate to complete the whole intervention
Key exclusion criteria (4 listed)
- primary malignant tumors in other parts
- history of severe heart, liver, kidney and other important organ failure, severe infection or mental illness
- Unable to cooperate with the study due to cognitive impairment, visual and hearing impairment
- participating in other similar nursing intervention studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routine nursing groupPatients in the routine group were given routine care, including disease monitoring, medication care, diet and nutrition guidance, basic life care, routine health education on admission and discharge, symptomatic treatment of patients' discomfort symptoms, telephone follow-up twice a week to understand the patient's condition, and no systematic and personalized SM nursing intervention. | Other | Routine nursing group |
| standardized systematic SM nursing groupOn the basis of routine nursing, implementation of systematic SM nursing intervention for 8 weeks, the specific content is as follows: (1) The intervention group was established. (2) Baseline assessment and file establishment (within 24 hours of admission).(3) Implementation of core intervention (1st to 8th week). | Other | standardized systematic SM nursing group |
Primary outcome
Change in Quality of Life as measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale
Time frame: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
The Functional Assessment of Cancer Therapy-Lung (FACT-L) scale will be used to assess changes in quality of life in patients with advanced lung cancer. The scale consists of 36 items across five domains: physical health status, social and family conditions, emotional well-being, functional capability, and lung cancer-specific supplementary concerns. Each item is scored on a 0-4 Likert scale, with total scores ranging from 0 to 144. Higher scores indicate better quality of life. The scale has demonstrated good reliability and validity in Chinese populations (Cronbach's α = 0.88-0.92).
2 secondary outcomes
Change in Self-Management Efficacy as measured by the Strategies Used by People to Promote Health (SUPPH) Scale
Time frame: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
Change in Psychological Resilience as measured by the Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine nursing group and standardized systematic SM nursing group in people with Symptom Managemen and Late Stage Lung Cancer, run by Jie Zeng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life as measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale (time frame: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.